Registration Services and Dossiers
Registration Services
We offer you a comprehensive service according to your requirements
- Execution of a national registration application
- Execution of de-central applications including the co-ordination of the RMS for the MRP
- Execution of central applications
- Execution of repeat use and line extension applications
- Execution of US-NDA’s
- Execution of non-European applications
- Execution of company registrations
- Execution of CoS-applications
- Execution of applications for medical devices and CE mark.
Compilation of dossiers
We compile your dossier according to the requirements of the authority and the market
- Compilation of SmPC’s and Physician inserts in consideration of the European reference products
- Compilation of the dossier according CTD-format 1-5 including handling of deficiency letters.
- Compilation of e-CTD
- Compilation of US NDA
- Compilation of Plant Master Files according USP, JP and EP
- Co-ordination of translations
- Co-ordination of clinical and pharmacological-toxicological expert reports
- Co-ordination of clinical studies for bioavailability and compatibility
Registration maintenance - dossier Up Dates
We take care that your dossier will be state of the art again
- Evaluation of the up-to-dateness of your dossier
- Assay of the conformance of the registration
- Implementation of change control-systems, their realizations and supervision
- Restructuring from NTA to CTD format
- Revision of quality expert reports
- Execution of the extension of the marketing authorisation and necessary changes
- Archiving of your documentation
- Coordination and preparation of PSUR and CIOMS
- Coordination of periodic literature searches in line with pharmaco-vigilance
- Handling of deficiency letters and completion of additional requirements after granting of the registration
- Implementation further manufacturer or change of manufacturer
- Implementation further API’s or change of API
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